Search for roles similar to 'Leader: Indication Prioritization and Clinical & Regulatory Strategy' in Boston, focusing on biomedical engineering or neuromodulation, with over 10 years of experience, full-time positions, and advanced degrees required.

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Leader: Indication Prioritization and Clinical & Regulatory Strategy

Boston, MA

Biomedical Engineering

10 years + Experience

PhD, MD, MS, or equivalent

Can you help me to analyze the job description and company culture?

Sure. Here's the analysis:

Job Analysis:

The role of Leader: Indication Prioritization and Clinical & Regulatory Strategy at Cahira Technologies Inc is fundamentally about driving the clinical translation and regulatory approval of groundbreaking nano-electronic implants for neural treatment and enhancement. This involves selecting and justifying the 'beach-head' disease indication, which is the first target condition to maximize clinical and market success. Responsibilities include developing comprehensive regulatory and clinical strategies to navigate the complex landscape of FDA and EU approvals, all while ensuring that the technology meets strict safety and efficacy standards. Candidates will likely face challenges such as balancing innovative technology with regulatory scrutiny, navigating the unpredictability of clinical trials, and aligning clinical objectives with market demands. Success in this role requires a vision for how these neural implants can benefit patients and a strategic mindset to effectively prioritize indications based on clinical viability and reimbursement potential. Moreover, effective communication with stakeholders – from regulatory bodies to investors – is essential to advocate for the technology and secure necessary approvals.

Company Analysis:

Cahira Technologies Inc stands at the cutting edge of neuroscience and medical technology as an MIT spinoff, innovating in a space that addresses the dire global need for effective treatments for neural disorders. With a mission to convert debilitating biological constraints into opportunities for augmentation, the company presents itself as a visionary disruptor in the medical device sector. Given its focus on non-surgical interventions, which significantly widen the patient base from traditional surgical methods, the role of Leader in Clinical & Regulatory Strategy is pivotal. The company likely promotes a culture of innovation and rapid iteration, which would attract candidates who thrive in fast-paced environments and can pivot quickly in the face of emerging data or competitive pressures. As this role involves high visibility within the organization, it’s crucial for the candidate to engage collaboratively across multidisciplinary teams while contributing to strategic discussions at the executive level. Ultimately, this role is not merely a clinical oversight position but a strategic enabler for expanding the company’s impact on a global scale, with a clear alignment of individual efforts to the broader mission of revolutionizing neural health.

Mock up some interview questions based on the job description.

Absolutely. Here are some mock interview questions that could come up:

Tell me about a time when you led a cross-functional team to select a product indication. What challenges did you face, and how did you overcome them?
Describe your experience with regulatory submissions, particularly in the context of Class III active implantable devices. Can you share a specific example?
How have you approached the task of developing clinical strategies for new medical technologies? What frameworks or methodologies do you favor?
Can you recount a situation where you had to communicate complex regulatory information to a non-technical audience? What was the outcome?
What specific skills do you possess that would help you navigate the FDA approval process for a novel implant device?
How would you prioritize the various indications for a device like ours? What factors would influence your decision-making process?
Imagine you are tasked with preparing for a pivotal trial, but initial results are not as favorable as expected. How would you handle this situation with stakeholders?
Suppose we are facing delays in obtaining necessary approvals. What steps would you take to mitigate these issues and keep the project on track?
Why are you interested in working at Cahira Technologies specifically, and how do you relate to our mission of eliminating barriers in neural health?
How do you envision integrating innovative technologies like AI into our clinical strategy, and what advantages could they bring?
What questions do you have about our existing regulatory strategies or the product development timeline?
Can you discuss any experience you have with health-economic modeling related to medical reimbursement? How could that knowledge benefit our projects?
What do you believe are the key attributes necessary for someone to excel in a startup environment like Cahira Technologies?
How do you stay updated with the latest trends and regulations in the neuromodulation field, and how can this benefit our efforts?

Job Details

Overview Company

Leader: Clinical & Regulatory Strategy

Cahira Technologies

5 days ago

Highlight

OnsiteFull-time10+ yearsSenior

Summary

Cahira Technologies is seeking a Leader: Indication Prioritization and Clinical & Regulatory Strategy (Nano-Electronic Neural Implants) to join their team in Boston, MA. The role involves leading the human-translation roadmap and indication-prioritization process for their nano-implant platform.

About the Role

As a Leader, you will select and justify the beach-head disease indication that maximizes clinical success, speed to market, reimbursement viability, and strategic value. You will build and execute the regulatory & clinical strategy (FDA, EU MDR, and key ROW jurisdictions) and define and drive the milestone plan from technology advancement and GLP studies to pivotal trials and market approval.

About You

Required:

10+ years in Class III active implantable devices with ≥5 years in neural implants, neuromodulation, or neurostimulation.
Direct, end-to-end experience bringing at least one neural or active implantable device from late pre-clinical through FDA approval and commercial launch.
Demonstrated leadership of indication-selection or product-market-fit efforts for a platform technology.
Deep knowledge of FDA IDE, PMA, De Novo, Breakthrough Devices Program, Q-Subs, and EU MDR processes.
Hands-on expertise in design-control, risk-management, biocompatibility, and electrical safety standards relevant to neural implants.
Advanced degree (PhD, MD, MS, or equivalent) in Biomedical Engineering, Neuroscience, Regulatory Affairs, or related discipline.
Outstanding written and verbal communication skills for regulatory dossiers, investor updates, and KOL engagement.

Preferred:

Experience with nano-scale or wirelessly powered implants.
Obtained Breakthrough Device Designation or HDE for a neurotechnology product.
Established network of FDA reviewers, neurology / neurosurgery investigators, and reimbursement experts.
RAC (US/EU) or PMP certification.
Familiarity with health-economic modeling and payer evidence requirements for neuromodulation therapies.
Exposure to AI/ML-enabled algorithms or digital companions integrated with implants.
Thrives in a fast-paced, resource-constrained startup environment and can scale teams rapidly.

Cahira Technologies

Cahira Technologies Inc is an MIT spinoff company founded by Prof. Deblina Sarkar (https://web.mit.edu/deblina-sarkar/). We have built the world’s first autonomous and non-surgical electronic implant for treating intractable neural diseases and for human augmentation.

Problem:

Human potential is constrained by diseases and limitations posed by biology.

According to the World Health Organization, over 3 billion people suffer from different neural disorders. Drugs are mostly ineffective, and typical implants are limited to only about 1% of patients, due to surgery costs, complications and risks.

Beyond diseases, biological restrictions such as our limited number of neurons and the way they process information, constrain human capabilities.

Our Solution:

Autonomous, non-surgical brain implants. Tech is already de-risked in clinical animal studies and has won multiple awards.

Our nanoelectronic devices can be introduced into the body without surgery and can autonomously implant in target brain regions. They co-live and co-exist with the brain cells enabling brain-computer symbiosis fusing into biology the capabilities of AI powered electronics.

Impact:

According to the World Health Organization, over 3 billion people suffer from neural disorders. However, today's surgical brain implants help <1% of patients due to their invasiveness, risks, and costs. By eliminating surgery, we are making our life-changing treatment accessible to all, removing barriers of age, health status, and cost that currently prevent millions from receiving treatment.

Beyond treating diseases, our unique brain-computer symbiosis, can enhance humans through precise modulation/enhancement of brain signals as well as drastically increasing neural density with synthetic electronic neurons which can communicate with each other and with the biological neurons for an augmented brain, transcending humans beyond biological limitations.

Boston, MA